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MinorPrimary completion date changed from estimate of Jun 30, 2026 to Jun 25, 2026Eligibility criteria expanded, about 27 words · Secondary endpoints: details revised at 33 of 55 entries · Site details revised at 1 of 110 sites · 1 moreShow 4 more changesShow less
Eligibility criteria expanded, about 27 words
Secondary endpoints: details revised at 33 of 55 entries
Site details revised at 1 of 110 sites
Publications: details revised at 1 of 1 entry
MinorEnrollment target: 984 to 982v29
NotableEnrollment increased: 540 → 984 participantsTrial status changed: Recruiting → Active, Not Recruiting · Trial sites reduced: 117 → 110 locations · Primary completion moved earlier from Aug 31, 2026 to Jun 30, 2026 · 1 morev28Show 4 more changesShow less
Trial status changed: Recruiting → Active, Not Recruiting
Trial sites reduced: 117 → 110 locations
Primary completion moved earlier from Aug 31, 2026 to Jun 30, 2026
Completion pushed from Jun 30, 2027 to Apr 30, 2028
MinorStudy sites: 115 to 117v27
MinorStudy sites: 113 to 115v26
Show 24 earlier versionsHide 24 earlier versions
MinorStudy sites: 111 to 113v25
MinorStudy sites: 108 to 111v24
MinorStudy sites: 106 to 108v23
MinorStudy sites: 105 to 106v22
MinorStudy sites: 98 to 105Primary completion date: Nov 30, 2026 to Aug 31, 2026 · Completion date: Sep 30, 2028 to Jun 30, 2027v21Show 2 more changesShow less
Primary completion date: Nov 30, 2026 to Aug 31, 2026
Completion date: Sep 30, 2028 to Jun 30, 2027
MinorStudy sites: 96 to 98v20
MinorStudy sites: 94 to 96Eligibility criteria expanded, about 17 wordsv19Show 1 more changeShow less
MinorPrimary completion date: Oct 31, 2026 to Nov 30, 2026Completion date: Aug 31, 2027 to Sep 30, 2028 · Eligibility criteria expanded, about 15 words · Secondary endpoints: 53 to 55v7Show 3 more changesShow less
MinorStudy sites: 1 to 3Start date: Jul 10, 2024 to Jul 31, 2024v3Show 1 more changeShow less
Start date: Jul 10, 2024 to Jul 31, 2024
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 1 · Start date changed from estimate of Jun 30, 2024 to Jul 10, 2024v2Show 2 more changesShow less
Study sites: 0 to 1
Start date changed from estimate of Jun 30, 2024 to Jul 10, 2024
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
One of the standard treatments for women with breast cancer is hormone therapy, but this treatment can cause hot flashes. Hormone replacement therapy, or HRT, is most often prescribed for hot flashes for women in menopause but cannot be given to women on hormone therapy for breast cancer. Fezolinetant, an alternative to HRT, treats hot flashes for women in menopause. As hot flashes happen in the same way for women on hormone therapy for breast cancer, fezolinetant could help these women. In this study, women on hormone therapy for breast cancer who have moderate to severe hot flashes will take part. They will either take fezolinetant or a placebo to treat their hot flashes. The placebo looks like fezolinetant but doesn't have any medicine in it.
The main aim of this study is to confirm if women who take fezolinetant have fewer hot flashes that are less severe compared to women who take the placebo.
Women 18 years or older seeking treatment for hot flashes. They can take part in the study if they have an average of 7 or more moderate to severe hot flashes each day. They are having hormone therapy for breast cancer from stage 0 (cancer cells that have not spread to nearby tissue) up to stage 3+ (the cancer has spread from the breast to the lymph nodes near the breast or the chest wall).
The women will be assigned 1 of 2 study treatments (fezolinetant or placebo) by chance alone. Treatment will be double-blinded. That means that the women in the study and the study doctors will not know who takes which of the study treatments (fezolinetant or placebo). Women who take part in the study will take 1 tablet every day for 52 weeks (1 year). Each woman will be given an electronic handheld device with an app to track their hot flashes on a daily basis. Some women may be able to use the app on their own smartphone. They will also use another device to answer questions about how hot flashes affect their daily life. During the study, the women will visit their study clinic about every 4 weeks for a health check. The last clinic visit will be 3 weeks after the women take their last tablet of study treatment (fezolinetant or placebo). After this visit the women will be called twice to check their health. The women will be in the study for about 2 years.